Reports of adverse events—bad results or low quality—come in through the FDA’s Center for Food Safety and Applied Nutrition system known as CAERS. Consumers and medical professionals submit reports that the FDA then evaluates “to monitor the safety of consumer products,” according to fda.gov.
“If a potential safety concern is identified in CAERS, further evaluation is performed. Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, communicate new safety information to the public, or, in rare cases, remove a product from the market.”
Data for all
The adverse event data will be publically available and published on a quarterly basis. To start, the FDA has published a backlog of adverse event reports from 2004 through September of this year. Previously this information was accessible only through the Freedom of Information Act.
Historically, the agency has used adverse event data “to support multiple actions by FDA [including] recalls…and investigations of cosmetic products, such as EOS lip balm and Brazilian BlowOut hair smoothing treatment.” (Find Cosmetics Design coverage of consumer concerns with EOS here and here.)
Industry regulations and transparency issues are overlapping more and more. For some this is good news. Others are concerned that the data will result in more class action proceedings.
In an item published on The National Law Review site this week, Keller and Heckman LLP, a firm specializing in regulatory litigation for business, commented that “increasing public access to adverse event information certainly represents an important step in transparency for the Agency; however, it also raises issues as to whether the information will be used to benefit consumer class action plaintiff’s lawyers as they search for their next target in the food, dietary supplement or cosmetic industries.”
The FDA acknowledges that adverse event reporting could be improved and that more comprehensive data will be more valuable. “There often are gaps in the information provided, which should ideally include the product name, symptoms, outcome, consumer’s sex and age, and the date the adverse event was experienced,” write Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, and Katherine Vierk, director of the division of public health informatics and analytics at the FDA’s Center for Food Safety and Applied Nutrition, in an item on FDA Voice explaining the agency’s decision to publish the event data regularly.
In a year or so the FDA will announce plans to improve the reporting system. The agency “intends to modernize the system to make reporting adverse events as user-friendly as possible,” note Mayne and Vierk. The FDA does not however verify that reported incidents and outcomes are in fact linked to the product indicated.